From PharmaTimes Online (link):
A UK-based pharma scientist has been sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform human trials.
Steven Eaton was found guilty at Edinburgh Sheriff’s Court in March following a prosecution under the Good Laboratory Practice Regulations 1999 – the first time the MHRA has successfully used these regulations to bring a prosecution.
The case came about when the US pharma firm Aptuit informed the MHRA that they had identified serious irregularities in pre-clinical data generated to support human clinical trials and the registration of new medicines.
The irregularities involved changing or providing false analytical data that would be used to determine the concentration of medicine that could be given to clinical trial subjects used to assess the safety and efficacy of a new medicine.
The MHRA’s investigation into the case found that an Aptuit researcher – Steven Eaton, 47 from Cambridgeshire – had selectively reported analytical data over a number of years, dating back to 2003. Eaton worked at the company’s drug discovery and development site in Riccarton, near Edinburgh, before being found out.
During this period he selectively reported data which was used to assess whether analytical methods were working properly or to assess the concentration of the drug in blood. The data manipulation ensured an experiment was deemed successful when in fact it had failed.
Eaton been working on pre-clinical trials in animals to assess the efficacy of new treatments on behalf of several major drug companies, including AstraZeneca and Roche. Aptuit had been carrying out the work on their behalf.
Sentencing him this week, Sheriff Michael O’Grady QC, said that a three month prison term was the longest sentence he could give Eaton under the Good Laboratory Practice Regulations.
He said: “I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly – you could have caused cancer patients unquestionable harm. Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable.”
The MHRA said this Eaton’s actions had wider consequences, and led to the review of many hundreds of safety studies assessing the impact of the data manipulation to ensure that the compromised data was not used in future submissions to relevant authorities without their knowledge.
Gerald Heddell, MHRA’s director of inspection, enforcement and standards said: “Mr Eaton’s actions directly impacted on the validity of clinical trials and delayed a number of medicines coming to market, including one to treat depression. The sentence sends a message that we will not hesitate to prosecute those whose actions have the potential to harm public health.”